Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01569763 |
Recruitment Status :
Completed
First Posted : April 3, 2012
Results First Posted : May 5, 2016
Last Update Posted : April 18, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menorrhagia | Device: Aurora Endometrial Ablation Device: Rollerball Ablation/Resection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Minerva Pivotal Study |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | March 2, 2018 |
Arm | Intervention/treatment |
---|---|
Active Comparator: hysteroscopic rollerball resection/ablation |
Device: Rollerball Ablation/Resection
Hysteroscopic rollerball resection/ablation |
Experimental: Aurora Endometrial Ablation |
Device: Aurora Endometrial Ablation
Endometrial Ablation using the Aurora Endometrial Ablation system |
- Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months [ Time Frame: 12 months ]Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.
- Procedure Time [ Time Frame: < 1 hour ]Procedure time is defined as the time from device insertion to time of device removal.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Refractory menorrhagia with no definable organic cause
- Female subject from (and including) age 25 to 50 years
- Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm
-
A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR,
- A minimum menstrual blood loss of ≥ 160 ml for one baseline cycle for women who either
- had at least 3 prior months documented failed medical therapy; or
- had a contraindication to medical therapy
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
- Not pregnant and no desire to conceive at any time
- Subject agrees to use a reliable form of contraception up to the 12-month follow-up visit. If a hormonal birth control method is used for contraception, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through the initial 12-month follow-up
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- Subject agrees to follow-up exams and data collection requirements
- Subject who is literate or demonstrates an understanding on how to collect menstrual blood loss products for the alkaline hematin method of analysis
Exclusion Criteria:
- Pregnancy or subject with a desire to conceive
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD)
- Presence of bacteremia, sepsis, or other active systemic infection
- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Known/suspected abdominal pelvic or gynecological malignancy within the past 5 years
- Known clotting defects or bleeding disorders
- Untreated/unevaluated cervical dysplasia, except CIN I
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
- Previous endometrial ablation procedure
- Presence of an implantable (intrauterine) contraceptive device (e.g. Essure™ or Adiana™)
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- Currently on anticoagulants
- Abnormal or obstructed cavity as confirmed by hysteroscopy, SIS or vaginal ultrasound
- Presence of an intrauterine device (IUD) which the Subject is unwilling to have removed at the time of the operative visit
- Subject currently on hormonal birth control therapy (including the Mirena device) for <3 months prior to enrollment
- Subject who is unwilling to use birth control post-ablation whether non-hormonal birth control or the same hormonal birth control therapy as before the procedure
- Subject who is within 6-weeks post partum
- Any subject who is currently participating or considers future participation in a research study of an investigational drug or device during the course of this investigational study
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569763
United States, Arizona | |
New Horizons Women's Care | |
Chandler, Arizona, United States, 85224 | |
Women's Health Research | |
Phoenix, Arizona, United States, 85015 | |
United States, Indiana | |
Basinski, LLC | |
Newburgh, Indiana, United States, 47630 | |
United States, Kansas | |
Cypress Medical Research Center, LLC | |
Wichita, Kansas, United States, 67226 | |
United States, Minnesota | |
Minnesota Gynecology and Surgery | |
Edina, Minnesota, United States, 55435 | |
United States, Missouri | |
Mercy Clinic Minimally Invasive Gynecology | |
Saint Louis, Missouri, United States, 63141 | |
United States, Tennessee | |
Tennessee Women's Care PC | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Baylor Research Institute | |
Fort Worth, Texas, United States, 76104 | |
Canada, Ontario | |
McMaster University/Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8N3Z5 | |
Canada, Quebec | |
Hôpital LaSalle | |
Ville Lassalle, Quebec, Canada, H8P 1C1 | |
Canada, Saskatchewan | |
Regina Qu'Appelle Health Region | |
Regina, Saskatchewan, Canada, S4S 6X3 | |
Canada | |
La Cite Medicale | |
Quebec, Canada, G1W 2J5 | |
Mexico | |
Hospital Universitario, UANL | |
Monterrey, Nuevo Leon, Mexico, 64460 |
Study Director: | Eugene Skalnyi, MD | Minerva Surgical, Inc. |
Responsible Party: | Minerva Surgical, Inc. |
ClinicalTrials.gov Identifier: | NCT01569763 |
Other Study ID Numbers: |
CIP0005 |
First Posted: | April 3, 2012 Key Record Dates |
Results First Posted: | May 5, 2016 |
Last Update Posted: | April 18, 2018 |
Last Verified: | March 2018 |
endometrial ablation |
Menorrhagia Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Diseases Hemorrhage Pathologic Processes Menstruation Disturbances |